2026-09-09 18:11:28 CET3124COVID-19 & Influenza A+B Antigen Combo Rapid Test (For Self-Testing)546Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnYesCommercialisedNoNoManualAntigenNasal swabSARS-CoVInfluenza AInfluenza B689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinNo2022-08-24 09:08:01 CET2832Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD130TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives13.64%PrecisionEvaluatedAccuracy97.35%COVID-19Accuracy100%InfluenzaReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity86.36%COVID-19Clinical Sensitivity100%InfluenzaClinical Specificity100%COVID-19Clinical Specificity100%InfluenzaType of antigenNucleocapsid protein3114COVID-19 Antigen Rapid Test (Saliva) for self-testing546Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnYesCommercialisedNoNoManualAntigenSalivaSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1439C.361224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinNo2022-08-24 09:08:01 CET2821Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD65TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives8.41AUPrecisionEvaluatedAccuracy98.4%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.59%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2288COVID-19 Antigen Rapid Test Kit (Salivia)1067Safecare Biotech (Hangzhou) Co. Ltd.Chinahttps://www.safecare.com.cnYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zeta2022-08-24 09:08:01 CET1989Immuno-AntigenImmunoassay10LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.75%(1 false positive from 132 tests)False negatives1.08%(2 false negative from 184 tests)PrecisionEvaluatedAccuracy99% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98% (Antigen)Clinical Specificity99% (Antigen)Type of antigenNucleoprotein1489COVID-19 Antigen Rapid Test Kit (Swab)546Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnYesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1234Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD0.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.96%False negatives0.56%PrecisionEvaluatedAccuracy98.41%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.04%Type of antigennucleoprotein2850COVID-19 Antigen Rapid Test Kit (Swab) for self-testing546Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnYesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2ZetaNo2022-08-24 09:08:01 CET2555Immuno-AntigenNoImmunoassayQualitativeSandwich, Double10LOD130TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3.6%PrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Clinical Specificity100%Type of antigenNucleocapsid protein1819COVID-19 Antigen Rapid Test Kit(Saliva)546Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnYesCommercialisedNoNoNear POC / POCAntigenSalivaLOD: 0.25ng/ml, Ct <=302022-08-24 09:08:01 CET1497Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD0.25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.55%False negatives1.5%PrecisionEvaluatedAccuracy99.05%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.5%Clinical Specificity99.45%2984COVID-19 Antigen Rapid Test Kit(Swab) for self-testing1319Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnYesCommercialisedNoNoManualAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinThe self-testing is certificated by NB 1434.2022-08-24 09:08:01 CET2690Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD130TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3.6%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein1035COVID-19 IgG/IgM Rapid Test Device (Whole Blood/Plasma/Serum)546Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnYesCommercialisedNoNoLab-basedNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaLOD: 10-time diluted of internal reference material2022-08-24 09:08:01 CET793Immuno-AntibodyYesNoImmunochromatographyQualitativeSandwich15LOD10AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives%9.19%False negatives%15.09%PrecisionEvaluatedAccuracy90.19%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity84.91%Clinical Specificity91.81%2199COVID-19 Neutralizing Antibody Rapid Test Kit( Whole blood/Serum/Plasma)1026Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnre.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaLoD:Internal positive control- 5 times diluted2022-08-24 09:08:01 CET1900Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)15LOD5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.24%False negatives0.71%PrecisionEvaluatedAccuracy99.52%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.29%Clinical Specificity99.76%Type of antigenNucleoprotein1490Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19)546Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnYesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1235Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10FP: FluA:0, FluB:0. FN: FluA:0.56%, FluB: 0. Accuracy: FluA:99.54%, FluB:100%. Clinical Sensitivity: FluA:100%, FluB:100%.LOD1.5AU1.5CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.96%COVID-19False positives0%FluBFalse positives0%FluAFalse negatives0.56%COVID-19False negatives0%FluBFalse negatives0.56%FluAPrecisionEvaluatedAccuracy100%FluBAccuracy99.54%FluAAccuracy98.41%COVID-19:ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%FluAClinical Sensitivity100%FluBClinical Sensitivity97.04%COVID-19Type of antigennucleoprotein